Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE W)

Phase 3

Terminated

• Conditions: Atrial Fibrillation; Vascular Risk

• Registration Number: NCT00243178
• Lead Sponsor: Sanofi

Brief Summary

The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a vitamin K antagonist) will result in the same risk of the composite outcome of stroke, non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-10-20
• Study First Submitted QC: 2005-10-20
• Study First Posted: 2005-10-21
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-16
• Last Update Posted: 2009-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6706

Inclusion Criteria

• Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or on two ECG recorded at two weeks a part during 6 months prior to study enrollment.

• Evidence of high risk of vascular events: at least one of the following risk criteria must be present:

  • are 75 years or greater;
  • on treatment for systemic hypertension;
  • prior stroke, TIA, or non-CNS systemic embolus;
  • left ventricular dysfunction with left ventricular ejection fraction (EF) estimated by echocardiogram or angiogram (radionuclide or contrast) to be < 45%;
  • peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation, or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio < 0.9);
  • age 55 to 74 years; AND
  • either diabetes mellitus requiring drug therapy, or documented previous myocardial infarction, or documented coronary artery disease.

Exclusion Criteria

• Patients will be excluded from ACTIVE if any of the following are present :

  • requirement for clopidogrel (such as recent coronary stent procedure);
  • requirement for oral anticoagulant (such as prosthetic mechanical heart valve);
  • prior intolerance to ASA or clopidogrel;
  • documented peptic ulcer disease within the previous 6 months;
  • prior intracerebral hemorrhage;
  • significant thrombocytopenia; (platelet count < 50 x 10(9)/L);
  • psychosocial reason making study participation impractical;
  • geographic reason making study participation impractical;
  • ongoing alcohol abuse;
  • mitral stenosis;
  • pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study;
  • severe comorbid condition such that the patient is not expected to survive 6 months;
  • patient currently receiving an investigational pharmacologic agent; OR
  • requirement for chronic (> 3 months) non-COX-2 inhibitor NSAID therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death	during approximately three years of follow-up

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes: major hemorrhage, total mortality and stroke.	during approximately three years of follow-up

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇬🇧 Guildford Surrey, United Kingdom